100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston’s tainted tests

Quote

“If there are problems with the scientific studies, as there have been in this case, then the FDA’s review of those problems needs to be transparent,” said David Kessler, who headed the FDA from 1990 to 1997 and who is now a professor at the University of California at San Francisco. Putting its reviews in public view would let the medical community “understand the basis for the agency’s actions,” he said. “FDA may be right here, but if it wants public confidence, they should be transparent. Otherwise it’s just a black box.”

On Friday, a coalition of public interest groups sent a letter urging FDA to overturn its policy of redacting certain information from federal documents before turning them over to journalists, regulators and others requesting the data, the AP/Washington Post reports.

as FDA figures out how to absorb the $209 million cut to food and drug regulation, the agency is saying food safety inspections will be spared too. FDA will scale back training and travel and not facility inspections

In a ruling May 17, Judge Phyllis Hamilton of the Oakland U.S. District Court said FDA and CFS now have until June 10 to agree on a schedule for releasing the yet-unpublished food safety rules, mandated by the Food Safety Modernization Act of 2011.

it appears that the F.D.A. has once again refused to do all it could to protect public health.

Quote

I think we’re looking at an industry-friendly response to the public health emergency of diseases caused by antibiotic-resistant bacteria, resistance that is bred in industrially raised animals.

Quote

Michael Taylor, the agency’s deputy commissioner for foods and veterinary medicine (and — just in case you think the notion that there is a revolving door between the F.D.A. and the food industry is hyperbole — a former vice president for public policy at Monsanto)

The replay of the December 11 FDA's teleconference, which I attended (available by calling 866-501-0089), gives the strong impression that the FDA's top priority is to not upset the pharmaceutical industry's apple cart.

The U.S. Food and Drug Administration has reached a settlement with the Center for Food Safety (CFS) and the Center for Environmental Health regarding the deadlines for publishing final rules implementing the Food Safety Modernization Act (FSMA).

When the Food and Drug Administration unveiled its revision of the iconic Nutrition Facts label that appears on processed foods and beverages earlier this year, nutritionists and consumer groups applauded the changes.

Quote

industry has been reviewing the agency’s proposal, preparing to mount what will likely be a hefty pushback.

Experts say the nutrition label should be revisited more frequently to keep up with research. But the FDA wants to make sure scientific evidence is solid before updating regulations. That can cause the government to lag behind research, said former FDA official Jim O’Hara, an original developer of the nutrition label and current director of health promotion policy at the Center for Science in the Public Interest.

On Thursday, 5 June 2014 the full US Senate voted 78-17 to confirm Sylvia Matthews Burwell, former director of the Office of Management and Budget (OMB), to the position of secretary of the Department of Health and Human Services (DHHS).

Gone are the days when an agency received a petition, especially from a consumer organization, and the optimal course of action was to do nothing. Inaction today will buy you a greater resource burn down the road, along with media attacks and cries of inefficiency and inappropriate public health priorities.